EAL

DLM: Medical Nutrition Therapy (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare a 10-munite brief dietary counseling program based on visualization of the plate model to that of a individualized counseling program based on the Step I diet on food intake.

Inclusion Criteria:

Men and women, £70 years with ischemic heart disease (previous MI or coronary revascularization)

Exclusion Criteria:

Patients with heart failure, diabetes, or dietary counseling from a dietitian within the past 2 years.

Description of Study Protocol:

Recruitment

Design

Patients with TC >5.5 mmol/L were treated with simvastatin.

30 minute one-on-one instruction on how to complete a food record (weigh and record foods)

Blinding used (if applicable)

Intervention (if applicable)

Randomly assigned to brief counseling (BCG) or comprehensive counseling (CCG). Both counseling types were given by the same dietitian.

Statistical Analysis

Data Collection Summary:

Timing of Measurements

Diet records taken at week 12 and 52.

Dependent Variables

Diet records
Assessed changes in intake of fat and saturated fat and intake of various food groups-with an emphasis on fish, fruits and vegetables after 1 year of counseling.

Independent Variables

Brief counseling (BCG): single 10 minutes session. Patients were offered 5 pieces of advice: eat several fruits daily; at the main meal use the Plate Model, this is dividing the plate into 4 sections: one for meat, fish, poultry, other animal product, the others for vegetables, grains and fruits; cut fat from steaks, roasts and the like; eat fish 2x/week; and when buying foods buy equally from the plant and animal kingdom.

Comprehensive (CCG): A 50-60 minute individualized tailored comprehensive consultation that included a diet history, information about blood cholesterol and dietary influence on blood cholesterol levels, ways to limit fat and saturated fat, and prefer choices of spreads and oils. Limits for fats (<30%) and saturated (<10%) were provided. Information about the importance of eating fish, fruits and vegetables was given. All information given was confined to the patient’s food preferences and diet history. After the second food records, patients received a 40-50 minute counseling session where compliance was evaluated via interview. Dietary advice was reinforced and additional information and recipes were given.

Control Variables

Description of Actual Data Sample:

Initial N: 44 were randomly assigned; BCG: 22 CCG: 22

Attrition (final N): BCG: 17 completed final food record; CCG: 19 completed final food
record; 18% total drop-out rate

Age: BCG: 56.6 +/16.2 CCG: 56.2 +/-8.2

Ethnicity:

Other relevant demographics: BCG: 15 males/2 females CCG: 16 males/3 females

Anthropometrics (both groups were similar with no statisitically difference)

Weight: BCG: 83 +/1 11.3 CCG: 78.8 +/-14.5

BMI:BCG: 27.1 +/-2.2 CCG: 26 +/-1 2.9

TC: BCG: 6.4 +/-1.2 mmol/L CCG: 6.2 +/-0.8 mmol/L

Summary of Results:

No statistically significant changes in any nutrients from baseline to wk 52 in BCG

CCG

% fat, saturated fat and carbohydrate intake were statistically significant from baseline to wk 52.

%fat: -4.8% mean P<0.005

%SF: -2.7% mean P<0.005

%carbs: 3.9% mean P<0.05

BCG (n=17)

Food (g/d) WkO Wk52 Change

Veg. 236 224 3

Fruit 163 129 -7

Milk 172 130 3

Meat 79 97 13

Poultry 18 29 16

Fish 48 44 0

Butter/oil 17 16 4

CCG (n=19)

Food (g/d) WkO Wk52 Change

Veg. 297 315 11

Fruit 205 172 -79

Milk 123 61 -26

Meat 105 76 -26

Poultry 14 39 14

Fish 32 44 10

Butter/oil 22 20 -1

Meat is the only food different from baseline to week 52 between groups, P 0.01

42% of the change in energy from fat was explained by changes in butter and oil, even after including other explanatory variable (adjusted R²=0.57, P<0.0005).

Variables	Treatment Group Measures and confidence intervals	Control group Measures and confidence intervals	Statistical Significance of Group Difference
Dep var 1	Mean, CI. e.g., 4.5±2.2	Mean, CI. e.g., 1.5±2.0	Stat signif difference between groups e.g., p=.002
Dep var 2
etc

Other Findings

Author Conclusion:

Patients in BCG insignificantly increased their intake of fat and saturated fat Only the CCG patients were able to maintain the low intake of total and saturated fat and the high carbohydrate intake after one year.

This suggests that dietary counseling given during the two 50-minute sessions in CCG does improve long-term dietary behavior regarding macronutrient intake, even at intake already close to recommendations. Long-term changes were not achieved by the 10-minute short advice based on the Plate Model. This indicated that simple behavioral advice is not effective at introducing dietary changes.

Funding Source:

Not-for-profit

Foundation associated with industry:

Reviewer Comments:

Did not track reason for dropout. More dropout in the BCG than the CCG. Based on self-reported food records. Subjects are not generalizable as they were from a cardiac rehab population. However booth groups were from this population, which makes the groups comparable. No mention of blinding but this would be a hard intervention to use blinding.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	N/A
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	N/A
	1.3.	Were the target population and setting specified?	N/A
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	N/A
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	???
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	N/A
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	N/A
	9.2.	Are biases and study limitations identified and discussed?	N/A
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	N/A
	10.2.	Was the study free from apparent conflict of interest?	N/A